OnCo
trialsTrialPositive

ALINA

Showed that giving an ALK pill after surgery, instead of chemotherapy, sharply reduces recurrence, including in the brain.

257 patients. DFS HR 0.24 in stage II-IIIA (2-year DFS 93.8% vs 63.0%); CNS-DFS HR 0.22. FDA approval April 2024. Follows the ADAURA template for EGFR.

Setting
Adjuvant alectinib 2 years vs platinum chemotherapy after resection of stage IB (≥4 cm)-IIIA ALK-positive NSCLC
Phase
Phase 3
Sponsor
Roche
Registry
NCT03456076
Headline result
DFS HR 0.24.
Reported
2023
Enrolled
257
Replication
Mirrors ADAURA (adjuvant osimertinib) for a second oncogene; OS immature.

Outcomes

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In plain words
What these results mean for people, not percentages
257 people took part
Disease-free survival, stage II–IIIAprimarysurrogate endpoint
  • Median 44.4 months with Platinum chemotherapy.
  • Alectinib: Median not reached.
  • "Not reached" means that, when the data were analysed, more than half of that group had not yet had the event, which is good news for that group.
  • A median is a midpoint: half the people did better than this and half did worse.
  • Put another way, the treated group had about 76 percent lower chance of the event at any given time (hazard ratio 0.24, likely range 0.13 to 0.45).
  • This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
  • These results apply to the people the trial enrolled: Adjuvant alectinib 2 years vs platinum chemotherapy after resection of stage IB (≥4 cm)-IIIA ALK-positive NSCLC. People in a different situation may not see the same effect.
  • The trial selected people by a biomarker (ALK); the result should not be assumed for people whose cancer does not have it.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

257 participants enrolled.

Disease-free survival, stage II–IIIAprimary
HR 0.24 (0.13–0.45) · p <0.001
Alectinib
Median not reached
Platinum chemotherapy
44.4 mo

Median not reached

Source
EndpointArmnValueHR (95% CI)pSource
Disease-free survival, stage II–IIIAprimaryAlectinib116Median not reached0.24 (0.13–0.45)<0.001link
Platinum chemotherapy11544.4 months
Replication
Mirrors ADAURA (adjuvant osimertinib) for a second oncogene; OS immature.

Connected

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Pages like this

not linked directly; found by shared links

cancers

1
Non-small-cell lung cancer

targets

1
ALK

drugs

1
ApprovedSmall-molecule kinase inhibitor (ALK)
Alectinib · Alecensa

trials

1
ADAURA

ideas

2
Prevention trials aimed only at brain metastasisStop excluding brain metastases from cancer trials